Drug recall D-1120-2019
Product
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Reason for recall
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Lots and codes
Lot 17181491 Exp. Aug. 2021
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 2076 500-count Bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 25, 2019
- Terminated
- September 14, 2020
Related products
- Pravastatin Sodium – drug information
- NDC 68462-198 Pravastatin Sodium · Pravastatin Sodium 80 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-197 Pravastatin Sodium · Pravastatin Sodium 40 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-195 Pravastatin Sodium · Pravastatin Sodium 10 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-196 Pravastatin Sodium · Pravastatin Sodium 20 mg/1 · Glenmark Pharmaceuticals Inc., USA